Diet Changes for Depression

Overseen By Ashley Gearhardt, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Lithium

Disqualifiers: Diabetes, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether reducing ultra-processed food (UPF) intake might improve depression symptoms. Researchers aim to determine if UPFs contribute to low mood and poor sleep, potentially leading to increased consumption of these foods. Participants will either receive meal kits with minimally processed foods or receive nutritional guidance to compare the effects. Ideal candidates for the trial are those with moderate-to-severe depression who regularly consume UPFs. As an unphased trial, this study provides a unique opportunity to contribute to understanding the impact of diet on mental health.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that impact reward, eating, or indicate severe mental health conditions, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that consuming a lot of ultra-processed foods (UPFs) links to health problems. Studies have found that a high intake of UPFs can lead to weight gain, heart issues, and mental health effects. For instance, one study found that people who consume more UPFs are more likely to feel depressed, particularly if they do not exercise much.

This trial focuses on a diet low in UPFs. Although specific data on the safety of this exact treatment is not available, reducing UPF intake generally poses fewer health risks. Since the trial aims to lower UPF consumption and provide healthy meals, the treatment is likely safe. However, consulting a healthcare provider before making dietary changes is important, especially for those with existing health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore the potential of dietary changes, specifically a low ultra-processed food (UPF) diet, to alleviate depression. Unlike standard treatments like antidepressants and therapy, which focus on chemical imbalances and psychological support, these interventions aim to improve mental health by altering dietary habits. The "Meal Delivery" approach provides participants with pre-prepared low UPF meals, making it easier for them to adhere to the diet, while the "Nutritional Guidance" arm offers education and snack boxes to empower individuals to make healthier food choices independently. By targeting diet as a factor in depression, these treatments could offer a non-pharmaceutical option that addresses the condition from a nutritional perspective.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that eating fewer ultra-processed foods (UPFs) might reduce the risk of depression. One study found that people who ate less UPF experienced fewer signs of depression. Another study linked eating more UPFs to worse mental health, including a higher risk of depression. UPFs may cause quick spikes in blood sugar, leading to mood swings and poor sleep, both of which relate to depression. In this trial, participants will receive either meal delivery or nutritional guidance to follow a low UPF diet. By choosing meals with fewer processed ingredients, participants might see improvements in mood and sleep. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with moderate-to-severe depression. It explores the relationship between eating ultra-processed foods (UPFs), mood, and sleep, as well as testing if a 2-week meal-kit of minimally processed foods can help reduce depression symptoms.

Inclusion Criteria

Willing to follow dietary guidelines

I can join a consent call via Zoom or phone.

Must own an Android or iPhone smartphone

Exclusion Criteria

Current pregnancy, breast-feeding, trying to get pregnant, or within six months of having given birth

I have taken medication for severe mental health conditions.

I was diagnosed with an eating disorder like anorexia or bulimia in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete questionnaires, interviews, and body composition measurements; remote tasks are completed while eating their typical diet

1 week

1 visit (in-person), remote tasks

Dietary Intervention

Participants are randomly assigned to a meal delivery or control condition; complete remote tasks while following dietary guidance

2 weeks

1 visit (in-person), remote tasks

Post-Intervention Assessment

Participants complete questionnaires, interviews, and body composition measurements

1 day

1 visit (in-person)

Follow-up

Participants are contacted to complete a short follow-up survey and provide information about their current diet

6 months

Remote assessments at 1 month and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Low UPF Diet

Trial Overview Participants will either follow a self-guided low UPF diet or receive a study-provided low UPF diet through meal kits. The goal is to see if these diets can improve mood and sleep by stabilizing blood glucose levels, thereby reducing depression symptoms.

How Is the Trial Designed?

Group I: Nutritional Guidance Experimental Treatment 2 Interventions

Dietary change (nutritional guidance) Visit 1 and the following week comprise the baseline assessment period. Visit 2 and the following week comprise the dietary intervention period. Nutritional guidance is provided by the study team for 14 days in accordance with a low UPF diet. Participants are delivered a box of snacks consistent with a low UPF diet. Visit 3 comprises post-intervention assessment. All participants will complete remote assessments at 1 month and 6 month follow ups.

Group II: Meal Delivery Experimental Treatment 2 Interventions

Dietary change (low ultra-processed meal delivery) and nutrition guidance to follow a low UPF diet. All participants complete a series of three in-lab visits with remote data collection: Visit 1 and the following week comprise the baseline assessment period. Visit 2 and the following 2 weeks comprise the dietary intervention period. Meal delivery and nutritional guidance is provided by the study team for 14 days in accordance with a low UPF diet. Visit 3 comprises post-intervention assessment All participants will complete remote assessments at 1 month and 6 month follow-ups.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809727

Consumption of Ultraprocessed Food and Risk of Depression In an exploratory analysis, those who reduced UPF intake by at least 3 servings per day were at lower risk of depression (strict definition: HR, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10512104/

Consumption of Ultraprocessed Food and Risk of Depression In an exploratory analysis, those who reduced UPF intake by at least 3 servings per day were at lower risk of depression (strict definition: HR, ...

3. bmj.com bmj.com/content/384/bmj-2023-077310

Ultra-processed food exposure and adverse health outcomes Greater exposure to ultra-processed food was associated with a higher risk of adverse health outcomes, especially cardiometabolic, common mental disorder, and ...

4. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-025-04002-4

The risk associated with ultra-processed food intake on ... A higher level of UPF consumption was associated with a higher risk of depressive symptoms and adversely affected mental health among older adults.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S026156142400102X

Adherence to the ultra-processed dietary pattern and risk of ... In conclusion, our study found that a higher adherence to the ultra-processed dietary pattern was associated with a higher risk of incident depressive symptoms ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7399967/

Ultra-Processed Foods and Health Outcomes: A Narrative ... 37 found dietary UPF exposure associated with at least one adverse health outcome. Among adults, these included overweight, obesity and cardio-metabolic risks.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7770142/

Ultra-Processed Food Is Positively Associated With ... The study suggests that UPF may increase the risk of depressive symptoms, particularly in people with less exercise.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0261561424001225

Ultra-processed foods and human health: An umbrella ... A previous review of UPFs published by Lane et al., has showed that UPF consumption was associated with adverse health outcomes, including overweight, obesity, ...